Smith+Nephew

China Regulatory Affairs Specialist

HKG - Shatin

hirly Pro

Get in front of the people hiring at Smith+Nephew

Reach the hiring manager at Smith+Nephew on LinkedIn, from your own account
hirly applies to this job for you, with unlimited applications
A resume and cover letter written for this job, unlimited
The hiring manager and recruiter at Smith+Nephew, with contact details

Get Pro for this job →

$49 a month · ₹1,999 for 30 days in India · cancel any time

Get past the screening software and onto a recruiter's desk

hirly rewrites your resume for this job — matching the keywords and skills in the posting, moving your most relevant experience to the top, and writing a cover letter to fit. About 30 seconds.

Keywords matched to this posting
Fit score before you apply
Cover letter included

Matched against 3M live jobs from 220,000+ employers in 200+ countries.

Tailor my resume for this job →

Apply from your AI assistant

Connect hirly to Claude or ChatGPT and ask it to apply to this job. hirly tailors your resume, fills the employer’s form and asks before sending.

See how it works

Some employer sites stop an application at a CAPTCHA or sign-in and hand it back with a link. Applying needs a paid plan. Works with any assistant that supports MCP.

hirly's read of this role

Seniority: Mid level
Country: HK
Work mode: On-site / unstated
First seen by hirly: 4 Nov 2026

Derived automatically from the posting. Upload your resume above to see how the role scores against it.

the posting

Regulatory Affairs Operations

Prepare, compile, review, and submit regulatory documentation for product registrations, renewals, amendments, notifications, and other lifecycle management activities in Hong Kong and Macau.

Coordinate with internal stakeholders to obtain required technical, quality, clinical, and regulatory documentation to support submissions.

Maintain regulatory licenses, approvals, certificates, and product registration databases to ensure continued compliance.

Monitor approval status and follow up on regulatory submissions to support timely market access.

Support regulatory assessments for product changes, labeling updates, manufacturing changes, and other regulatory impact evaluations.

Quality Assurance Activities

Support complaint handling activities in accordance with company procedures and applicable regulatory requirements.

Assist with complaint documentation, investigation follow-up, trending, and record maintenance.

Support post-market surveillance and vigilance activities where applicable.

Maintain quality records and documentation in compliance with Quality Management System requirements.

Assist with field actions, recalls, advisory notices, and other quality-related activities as required.

Regional Regulatory Support

Prepare and submit regulatory dossiers for assigned international markets.

Coordinate with distributors, authorized representatives, and internal stakeholders to support registration and maintenance activities.

Support responses to regulatory authority questions and requests for additional information.

Maintain regulatory records and approval status tracking for assigned markets.

Participate in new product launch and market expansion projects from a regulatory perspective.

Stay connected by joining our Talent Community .

We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.

Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited. , life, culture, and benefits at S+N.

Explore our website and learn more about our mission, our team, and the opportunities we offer.

Original posting on Smith+Nephew's site ↗

Listed on hirly, a job board. hirly is not the employer: Smith+Nephew is hiring for this role.

Browse similar roles

More roles at Smith+Nephew

Want this one?

Upload your resume and hirly rewrites it for this job and writes the cover letter — in about thirty seconds, before you sign up.

Tailor my resume for this job